PRIALT

Product NDC: 68118-722
Requested package NDC: 68118-722-10
11-digit product format: 681180722
Labeler code: 68118
Product ID: 68118-722_57e9b601-e657-b5ef-e063-6394a90af39f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ziconotide acetate
Dosage form: INJECTION, SOLUTION
Route: INTRATHECAL
Labeler: ESTEVE PHARMACEUTICALS, S.A.
Application: NDA021060
Marketing category: NDA
Marketing start: 2018-10-15
Substance: ZICONOTIDE ACETATE
Active strength: 500 ug/5mL
Pharmacologic classes: N-Calcium Channel Receptor Antagonists [MoA]; N-type Calcium Channel Antagonist [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021060-001	PRIALT	ZICONOTIDE ACETATE	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28
N021060-002	PRIALT	ZICONOTIDE ACETATE	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28
N021060-003	PRIALT	ZICONOTIDE ACETATE	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28
N021060-004	PRIALT	ZICONOTIDE ACETATE	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021060-001	PRIALT	500MCG/20ML (25MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021060-002	PRIALT	100MCG/1ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021060-003	PRIALT	200MCG/2ML (100MCG/ML)	INJECTABLE / INTRATHECAL		2004-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021060-004	PRIALT	500MCG/5ML (100MCG/ML)	INJECTABLE / INTRATHECAL	RLD, RS	2004-12-28	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 700 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-001	8653033	2024-10-01	U-55	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-001	8653033	2024-10-01	U-48	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-001	8765680	2024-10-01	U-55	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-001	8765680	2024-10-01	U-48	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-001	9707270	2024-10-01	U-2084	2017-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-002	8653033	2024-10-01	U-48	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-002	8653033	2024-10-01	U-55	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-002	8765680	2024-10-01	U-48	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-002	8765680	2024-10-01	U-55	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-002	9707270	2024-10-01	U-2084	2017-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-003	8653033	2024-10-01	U-48	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-003	8653033	2024-10-01	U-55	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-003	8765680	2024-10-01	U-48	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-003	8765680	2024-10-01	U-55	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-003	9707270	2024-10-01	U-2084	2017-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-004	8653033	2024-10-01	U-55	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-004	8653033	2024-10-01	U-48	2014-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-004	8765680	2024-10-01	U-48	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-004	8765680	2024-10-01	U-55	2014-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021060-004	9707270	2024-10-01	U-2084	2017-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-001	8653033	2024-10-01	U-55	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-001	8653033	2024-10-01	U-48	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-001	8765680	2024-10-01	U-55	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-001	8765680	2024-10-01	U-48	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-001	9707270	2024-10-01	U-2084	2017-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-002	8653033	2024-10-01	U-48	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-002	8653033	2024-10-01	U-55	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-002	8765680	2024-10-01	U-48	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-002	8765680	2024-10-01	U-55	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-002	9707270	2024-10-01	U-2084	2017-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-003	8653033	2024-10-01	U-48	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-003	8653033	2024-10-01	U-55	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-003	8765680	2024-10-01	U-48	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-003	8765680	2024-10-01	U-55	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-003	9707270	2024-10-01	U-2084	2017-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-004	8653033	2024-10-01	U-55	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-004	8653033	2024-10-01	U-48	2014-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-004	8765680	2024-10-01	U-48	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-004	8765680	2024-10-01	U-55	2014-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021060-004	9707270	2024-10-01	U-2084	2017-08-16	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: PRIALT
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZICONOTIDE ACETATE	500 ug/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T2I226K69M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
486133	Internal RxNorm lookup
583453	Internal RxNorm lookup
1738353	Internal RxNorm lookup
1738354	Internal RxNorm lookup
1738357	Internal RxNorm lookup
1738358	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57376a5b-4530-9018-e063-6394a90a9afe	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRIALT	ZICONOTIDE ACETATE	ESTEVE PHARMACEUTICALS, S.A.	57376a5b-4530-9018-e063-6394a90a9afe	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021060 application number: NDA021060 ndc (package): 68118-722-10 ndc (product): 68118-722 ndc11 (package): 68118072210
PRIALT	ZICONOTIDE ACETATE	TerSera Therapeutics LLC	b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1	2025-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021060 application number: NDA021060

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T2I226K69M	ZICONOTIDE ACETATE	914454-03-8	ZICONOTIDE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Status
68118-722-10	68118072210	1 VIAL, GLASS in 1 CARTON (68118-722-10) / 5 mL in 1 VIAL, GLASS	2019-08-15	0	Current